NCT02083965

Pharmacokinetics of rFVIIIFc at Two Vial Strengths

A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetics of 2 Vial Strengths of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in Previously Treated Subjects With Severe Hemophilia A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Bioverativ Therapeutics Inc. · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.

Detailed description

This is a randomized, open-label, crossover study during which each participant receives a single injection of rFVIIIFc from 2 different vial concentrations (PK assessment). After the PK assessment, participants are provided with rFVIIIFc for either prophylactic or episodic (on-demand) treatment for up to 6 months.

Conditions

• Severe Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	rFVIIIFc	Administered as specified in the treatment arm.

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-10-01
• Completion: 2015-05-01
• First posted: 2014-03-11
• Last updated: 2020-12-19
• Results posted: 2016-08-19

Locations

8 sites across 3 countries: United States, Australia, United Kingdom